Market Overview

In order to break through the belated development of regenerative medicines, which has often been pointed out, the government enacted the Regenerative Medicine Promotion Act, aiming to propel the comprehensive development of regenerative medicines from R&D to practical application under the government-led initiative, including building of infrastructure and evaluation/judgement system for providing the medicines safely and securely. In response to this, the Act on Securing Safety of Regenerative Medicine and the PMD Act became effective in November, 2014. While the former Act defined the medical range/scope and the technologies used for achieving regenerative medicines and described a roadmap to practical application, the latter enacted regulations to pave the way for practical application and market release of regenerative medicine products according to their characteristics. 

Activities toward launching of the regenerative medicine market has been in progress, in the legal aspect where the government enforced related laws/regulations and also in the economic aspect, such as in the form of Regenerative Medicine Network Program, a national project that invests 110 billion yen for the studies and development of regenerative medicines during the next decade. 

Ever since JACE (human autologous tissue for transplantation) became the first insurance-covered regenerative medicine product in 2009, seven items have been approved as regenerative medicine products in Japan, including Kymriah (suspension for intravenous infusion) and Collategene (Intramuscular Injection 4 mg), among which six are covered by insurance. The seven such items can be categorized as follows: one item is the tissue product, 2 items are cell sheets, and four items are cell medicines.

Meanwhile, there are 66 items of major regenerative medicine products worldwide.  When observing them by country, South Korea has the largest number with 19 items, followed by the U.S. with 13 items. When observing them by region, Europe has the largest number with 19 items, the same as South Korea. Other countries include Canada, Australia, New Zealand, Singapore, and China.

*The number of items and other quantitative data is as of when the research took place.

Noteworthy Topics

Release of Regenerative Medicine Products

Stemirac, Kimriah, and Collategen® - newly approved regenerative medicine products have been released one after another during 2018 and 2019 period. Approval of these products made Japan to have seven items of regenerative medicines altogether, ever since when JACE (human autologous tissue for transplantation) had been approved as insured regenerative medicine product for the first time in Japan, which had been released in 2009. 

There have been more of such products currently under clinical development, which include medicines for cancers and central nervous system diseases. If the development progresses auspiciously, multiple products, one after another, are expected to be released in 2020 and beyond.

Also, there have been some attempts to maximize the values of existing regenerative medicine products by applying them to other symptoms and diseases: Temcell (human (allogeneic) bone marrow-derived mesenchymal stem cells) applying to remedy epidermolysis bullosa, JACE to congenital giant pigmented nevus, as well as to epidermolysis bullosa or secondary gonarthrosis caused by cultured cartilage being flawed. From the very beginning, the research and development have been carried out with franchising in view. Such development is expected to accelerate for the future.

Future Outlook

In the status where market players are increasing, the research and development of regenerative medicines have been underway: After approval of Kimriah, and Collategen®, Japan now has seven items approved as regenerative medicine products. In addition, increasing number of companies are planning to finish the clinical tests and apply for approval around 2020. If their attempts go smoothly, multiple products are expected to be released one after another for the future.

Clinical application of iPS Cells are underway, as they have been transplanted to a patient suffering from macular degeneration in 2014 and to a patient suffering from Parkinson disease in 2018. There are more plans for clinical studies on iPS cells, such as for aplastic anemia, severe ischemic cardiomyopathy, spinal cord injury, and exhaustion of corneal epithelial stem cells. Through the course of repetitive inspections to verify safety and effectiveness, studies on iPS cells are steadily in progress to be applied for disease treatment. 

Research Outline